Sodium Restriction in the Management of Cirrhotic Ascites

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Terminated
Phase 4

Conditions

Ascites

Treatments

Other: Sodium restriction

Study type

Interventional

Funder types

Other

Identifiers

NCT00548366
UTSouthwestern 062007-066

Details and patient eligibility

About

To determine the relationship between degree of sodium restriction and dietary compliance with clinical outcome of diuresis of portal hypertensive ascites in cirrhotic patients from a county hospital population. Primary objective: Demonstrate that, when accompanied by the appropriate diuretic regimen, a No Added Salt diet (4 grams sodium per day) is as effective as a Low Sodium diet (2 grams sodium per day) in the management of cirrhotic ascites.

Full description

Secondary objectives: Demonstrate that patient acceptance is greater and diuresis faster with a No Added Salt diet compared with a Low Sodium diet Demonstrate that side-effects of diuretic therapy are the same or less when patients are on a No Added Salt diet Determine if glomerular filtration rate estimated from the modified diet in renal disease equation differs from that obtained by a 24 hour urinary creatinine in patients with cirrhotic ascites

Enrollment

68 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Cirrhotic patients of any etiology with ascites from portal hypertension diagnosed by paracentesis,
  • Age 18-75
  • Clinical or radiographic (abdominal CT or ultrasound) estimate of moderate - severe ascites
  • Spanish-speaking subjects will be eligible for participation

Exclusion criteria

  • Active drug or alcohol abuse,
  • Active complications of SBP, hepatic encephalopathy, or GI bleed within 2 weeks,
  • Hemorrhagic ascites, malignant ascites,
  • Creatinine >2 mg/dL or CCl < 30 mL/min,
  • K > 5.5 mmol/L,
  • Diuretic refractory ascites
  • Allergy to or intolerance of either spironolactone or furosemide
  • Homelessness, incarceration, inability to follow up in clinic, or comply with diet.

Trial design

68 participants in 2 patient groups

1
Experimental group
Description:
4 gram sodium diet
Treatment:
Other: Sodium restriction
Other: Sodium restriction
2
Active Comparator group
Description:
2 gram sodium diet
Treatment:
Other: Sodium restriction
Other: Sodium restriction

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems